A 4-year study of Red Yeast Rice extract known as Xuezhikang which lowers cholesterol... Monday, July 27, PDF Free Download

A 4-year study of Red Yeast Rice extract known as Xuezhikang which lowers cholesterol... 1

At a dose of 600 mg twice a day... 2

Reduced coronary events by 37%... 3

Reduced death from coronary heart disease by 31%... 4

Reduced strokes by 44%... 5

Reduced the need for coronary bypass surgery by 49%... 6

Reduced cancers by 51%... 7

And, most importantly... 8

Reduced all-cause mortality by 32%. 9

As far as I know... 10

These benefits are VASTLY SUPERIOR to any study done with the cholesterol-lowering drugs known as statins. 11

Hi, this is Larry Hobbs @ FatNews.com 12

This according to a study done in China... 13

in people who were 65-75 years-old... 14

who had already had a heart attack. 15

735 were given the Red Yeast Rice extract. 16

And 710 were given a placebo. 17

This extract, Xuezhikang, contains: High amounts of lovastatin Unsaturated fatty acids Essential amino acids And other trace minerals 18

Lovastatin is the same chemical that is found in the cholesterollowering drug Mevacor. 19

Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 Effect of Xuezhikang on Cardiovascular Events and Mortality in Elderly Patients with a History of Myocardial Infarction: A Subgroup Analysis of Elderly Subjects from the China Coronary Secondary Prevention Study Ping Ye, MD, PhD, Zong-Liang Lu, MD, w Bao-min Du, MD, w Zuo Chen, MD, PhD, w Yang-Feng Wu, MD, PhD, w Xue-Hai Yu, MD, w and Yu-Cheng Zhao, MD, w for the CCSPS Investigators OBJECTIVES: To evaluate whether lipid-lowering therapy with xuezhikang reduces the risk of coronary events and total mortality in patients with coronary heart disease (CHD) aged 65 and older. DESIGN: Subgroup analysis of the China Coronary Secondary Prevention Study, a randomized, double-blind, placebo-controlled, clinical trial. SETTING: Sixty-six hospitals in China. PARTICIPANTS: A total of 1,445 patients, aged 65 to 75, were chosen from 4,780 patients with a history of myocarto all causes was estimated to be 18, 33, and 23, respectively. In a like manner, the estimated NNT to prevent one coronary event, one coronary death, and one mortality due to all causes in younger patients was 23, 82, and 51, respectively. There was not a significantly greater number of adverse effects in the xuezhikang group than in the placebo group. CONCLUSION: This is the first study demonstrating that treatment with xuezhikang capsules is safe and effective for the secondary prevention of CHD in older Chinese people. 20

with xuezhikang reduces the risk of coronary events and total mortality in patients with coronary heart disease (CHD) aged 65 and older. Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 DESIGN: Subgroup analysis of the China Coronary Secondary Prevention Study, a randomized, double-blind, placebo-controlled, clinical trial. SETTING: Sixty-six hospitals in China. PARTICIPANTS: A total of 1,445 patients, aged 65 to 75, were chosen from 4,780 patients with a history of myocardial infarction. INTERVENTION: The patients were randomized to the xuezhikang (n 5 735) or the placebo (n 5 710) group and followed for a mean of 4 years. t c t s a g C t t J K e MEASUREMENTS: The primary endpoint was recurrent 21

MEASUREMENTS: The primary endpoint was recurrent coronary events; the secondary endpoint was all-cause mortality and other clinical events, including adverse effects. Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 RESULTS: Elderly patients were at greater risk for coronary events, death from coronary events, all-cause mortality, and malignancies than younger patients. Xuezhikang therapy reduced the incidence of coronary events 36.9% (P 5.001), death from coronary heart disease 31.0% (P 5.04), all-cause mortality 31.9% (P 5.01), stroke 44.1% (P 5.04), the need for a percutaneous coronary intervention or coronary artery bypass graft 48.6% (P 5.07), and malignancies 51.4% (P 5.03). Based on the treatment of elderly patients with xuezhikang for an average of 4 years, the number needed to treat (NNT) to prevent one Cth in fe a m th p h 25

Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 1016 YE ET AL. JULY 2007 VOL. 55, NO. 7 JAGS marked modulating effect on lipid levels with an excellent safety profile. 8,9 In the Chinese Ninth Five-year plan, the National Scientific and Technological Project supported the China Coronary Secondary Prevention Study (CCSPS), which was the first CHD secondary prevention trial in China involving xuezhikang, between May 1996 and May 2004. 10 The data generated in the CCSPS pertaining to the prevention of CHD in elderly patients treated with xuezhikang were analyzed using subgroup analysis in an effort to ascertain whether the treatment effects in elderly patients differed from those in younger patients. The risk of adverse effects associated with the treatment with xuezhikang in elderly patients was also determined. PATIENTS AND METHODS Patient Population Between November 1, 1996, and December 31, 2000, patients were screened and enrolled from 66 hospitals in China. Eligible subjects were men and women aged 18 to 75 The primary study endpoint used to assess the treatment effects of xuezhikang was the total number of CHD events, including recurrent nonfatal MI, fatal MI, sudden death, and other coronary deaths. The secondary study endpoint was mortality due to all causes. Other events recorded and analyzed included cancer, stroke, and requirement for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) procedures. Routine follow-up visits to monitor clinical events were scheduled in the clinics of the participating hospitals 6 to 8 weeks after randomization and then every 6 months until the final follow-up visits between January and May 2004. At each visit, data on treatment compliance, concomitant use of other medications, onset of clinical events, occurrence of adverse effects, and laboratory tests, including serum lipid levels (TC, TG, LDL-C, and high-density lipoprotein cholesterol (HDL-C)) and safety parameters (alanine aminotransferase, aspartate aminotransferase, creatine kinase, urea nitrogen, and creatinine levels) were collected. An electrocardiogram was obtained yearly. During the study, patients were asked to continue the study 31

baseline characteristics of the CCSPS have been described in Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 detail elsewhere. 10 The current study was a randomized, double-blind, placebo-controlled, clinical trial. Randomization was done according to the number allocated to each hospital by the study data center. Adherent individuals who did not have major clinical events or other serious medical conditions during the run-in were randomly allocated to receive a xuezhikang capsule, 0.6 g twice daily (Beijing WBL Peking University Biotech Co., Ltd., Beijing, China), or a matching placebo twice daily. Previous medical treatments for hypertension, CHD, or complications of CHD were continued, but all medications known to influence blood lipid levels were prohibited. St D 1 m to u h ri w re tr si 32

Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 JAGS JULY 2007 VOL. 55, NO. 7 EFFECT OF XUEZHIKANG IN PATIENTS WITH PREVIOUS MYOCARDIAL INFARCTION 1017 RESULTS Baseline Characteristics and Follow-Up There were 1,445 patients aged 65 to 75, of whom 735 were allocated to the xuezhikang group and 710 to the placebo group. Baseline characteristics such as nationality, cardiac risk factors, concurrent medications, and lipid levels of the xuezhikang and placebo groups were similar, with the exception of the concomitant use of nitrates, which was greater in the placebo group than in the xuezhikang group (Table 1). The average follow-up period for subjects was 4 years (range 0.5 7 years). Forty patients (1.6%) were lost to follow-up, of whom 14 were in the xuezhikang group and 26 the placebo group. Changes in Serum Lipid Levels Over an average of 4 years, xuezhikang therapy reduced average TC and LDL-C levels 12.1% and 17.7%, respectively, compared with a corresponding reduction of 2.4% Table 2. Fasting Lipid Levels over the Course of the Study Lipid Parameters Xuezhikang Group Placebo Group Mean Concentration, mg/dl (Percentage Change from Baseline) P- Value Total cholesterol Baseline 207 207 1 year 182 ( 12.1) 203 ( 1.9) 3 years 180 ( 13.0) 204 ( 1.4) 7 years 183 ( 11.6) 198 ( 4.3) Mean of follow-up period 182 ( 12.1) 202 ( 2.4) o.001 Low-density lipoprotein cholesterol Baseline 130 130 1 year 106 ( 18.5) 128 ( 1.5) 3 years 107 ( 17.7) 126 ( 3.1) 7 years 109 ( 16.9) 128 ( 1.5) Mean of follow-up period 107 ( 17.7) 127 ( 2.3) o.001 33

L Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 Changes in Serum Lipid Levels Over an average of 4 years, xuezhikang therapy reduced average TC and LDL-C levels 12.1% and 17.7%, respectively, compared with a corresponding reduction of 2.4% and 2.3% in the placebo group (Po.001). Triglyceride levels fell 12.4% in the xuezhikang group, compared with T 6.4% in the placebo group (Po.01). In addition, HDL-C levels rose 2.0% after xuezhikang therapy and fell 2.0% in the placebo group (Po.05; Table 2). 34

Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 1018 YE ET AL. JULY 2007 VOL. 55, NO. 7 JAGS The beneficial effect of xuezhikang on mortality was observed after 6 months of treatment and continued to increase during the follow-up period. Other clinical events that were monitored were cancer, stroke, and the need for PCI or CABG procedures. Fifty-one patients treated with xuezhikang and 94 treated with the placebo suffered from other clinical events; the risk was thus 47.6% less with xuezhikang (Po.001). Specifically, the incidence of stroke was 44.1% less (Po.05), the incidence of cancer was 51.4% less (Po.05), and the need for PCI or CABG procedures was 48.6% less (P4.05) with xuezhikang. A proportion without event The effect of xuezhikang on CHD events 1.00 xuezhikang.95.90 Placebo.85.80 0 1 2 3 4 5 6 7 8 years since randomization Comparison of Treatment Effect Between Elderly and Younger Patients Older age was found to be a significant risk factor for coronary events, death from coronary events, and mortality from all causes in the placebo-treated patients (Po.01 for all endpoints; Table 4). Furthermore, the risk of cancer was also significantly higher in elderly patients than in younger B with survival 1.00.98.96 The effect of xuezhikang on CHD death xuezhikang 36

and total mortality. Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 Adverse Effects Clinical adverse effects were rare and comparable in the xuezhikang and placebo groups (1.4% vs 2.04%, P4.05). There were 10 reported adverse effects in the placebo Fig on he car on group, including three patients with gastrointestinal discomfort, three patients with allergic reactions, and four patients with myalgias, psychoneurological symptoms, erectile dysfunction, or edema. Eighteen patients in the xuezhikang group were reported to have adverse effects: gastrointestinal discomfort in nine patients, allergic reactions in four patients, myalgias in three patients, and edema in two patients. DI Th 37

Clinical adverse effects were rare and comparable in the Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 xuezhikang and placebo groups (1.4% vs 2.04%, P4.05). There were 10 reported adverse effects in the placebo Fig ond hea car ona group, including three patients with gastrointestinal discomfort, three patients with allergic reactions, and four patients with myalgias, psychoneurological symptoms, erectile dysfunction, or edema. Eighteen patients in the xuezhikang group were reported to have adverse effects: gastrointestinal discomfort in nine patients, allergic reactions in four patients, myalgias in three patients, and edema in two patients. The levels of alanine aminotransferase more than three times the upper limit of normal occurred in two patients each in the xuezhikang (0.27%) and placebo groups (0.28%). No patients with creatine kinase levels more than five times the upper limit of normal occurred in either DI Th sig eve tal fol 38

xuezhikang group were reported to have adverse effects: Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 ona gastrointestinal discomfort in nine patients, allergic reactions in four patients, myalgias in three patients, and edema in two patients. The levels of alanine aminotransferase more than three times the upper limit of normal occurred in two patients each in the xuezhikang (0.27%) and placebo groups (0.28%). No patients with creatine kinase levels more than five times the upper limit of normal occurred in either group. Similarly, 32 patients (4.51%) in the xuezhikang group and 47 (6.39%) in the placebo group were reported to have serum creatinine levels beyond the upper limit of normal (4133 mmol/l), but this did not reach statistical significance (P4.05). The incidence of adverse effects was similar in elderly DIS The sign eve tali foll eter duc pop use kan rate 39

in two patients. Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 The levels of alanine aminotransferase more than three DIS The times the upper limit of normal occurred in two patients each in the xuezhikang (0.27%) and placebo groups (0.28%). No patients with creatine kinase levels more than five times the upper limit of normal occurred in either group. Similarly, 32 patients (4.51%) in the xuezhikang group and 47 (6.39%) in the placebo group were reported to have serum creatinine levels beyond the upper limit of normal (4133 mmol/l), but this did not reach statistical significance (P4.05). The incidence of adverse effects was similar in elderly and younger patients (1.8% vs 1.5%; P4.05). sign even talit foll eter duc pop used kan rate xue 41

Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 JAGS JULY 2007 VOL. 55, NO. 7 EFFECT OF XUEZHIKANG IN PATIENTS WITH PREVIOUS MYOCARDIAL INFARCTION 1021 MM, Zhang P); Liaoning People s Hospital (Deng CX, Liu Y, Li ZQ, Shi YQ, Hu TS); Chongqing Medical University First Hospital (Chen YZ, Tan S, Zhao WR, Deng GL, Huang WJ); Hebei Baoding Second Hospital (Zhang JC, Yu H, Shi QS, Wang XZ, Jiang B); Shangdong University Qilu Hospital (Pan XR, Li L, Pu PL, Shu MQ, Xu QL); Peking University First Hospital (Zhang JH, Ding WH, Li L, Yang JJ, Su JL); Anshan Steel Company Tiedong Hospital (Zhao WD, Liu X, Li LJ, Yang JF, Wang QS); Institute of Cardiology, Tianjing Medical University Second Hospital (Huang TG, Li LF, Zhou LJ); Peking University Third Hospital (Guo JX, Li WH, Li ZP); Beijing Fangshan First Hospital (Zhang XG, Peng XM, An YW); Xian Jiaotong University First Hospital (Shu J, Ma LT, Ge H, Zhang MJ, Lü ZR); Beijing Haidian Hospital (Li JH, Yang JW, Zhang L); Jiangsu People s Hospital (Cheng YL, Chen JG, Zhou CW, Zhang HH); Harbing Medical University First Hospital (Huang YL, Qu XF, Li JJ, Guo H); Shangdong Dezhou Hospital (Wang GX, Hao SZ, Li SJ, Chang HS); Beijing Military Area General Hospital (Zhou SM, Liang HQ, Cao SJ, Liu JG); Shanxi Hanzhong People s Hospital (Yang J, Zhao MY, Lü Y, Xu SL); Central South University Xiangya (He XN, Chen GL); Western China Hospital (Wang JL); Huazhong University of Science & Technology Tongji Medical College Wuhan Union Hospital (Liang GF, Dai GZ); and Beijing Fuxing Hospital (Wang Q); Henan People s Hospital (Jin HY). Associate Laboratory of Serum Lipid Measurement and Quality Control, Ministry of Health Institute of Geratology (Wang S). ACKNOWLEDGMENTS Financial Disclosure: This project (No.96-906-02-10) was supported by the National Medical Science and Technological Foundation during the 9th Five-Year Plan in China. Ping Ye, Zong-Liang Lu, Bao-Min Du, Zuo Chen, Yangfeng Wu, Xue-Hai Yu and Yu-cheng zhao received financial support by grants from National Medical Science and Technological Foundation, and Beijing WBL Peking University Biotech Co., Ltd. for this study. Author Contributions: Ping Ye collected and interpreted the data and designed and prepared the manuscript. Zong-LiAng Lu was involved in the design and interpreta- 42

- Geratology (Wang S). Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 l l ACKNOWLEDGMENTS Financial Disclosure: This project (No.96-906-02-10) was ; ;, l supported by the National Medical Science and Technological Foundation during the 9th Five-Year Plan in China. Ping Ye, Zong-Liang Lu, Bao-Min Du, Zuo Chen, Yangfeng Wu, Xue-Hai Yu and Yu-cheng zhao received financial support by grants from National Medical Science and Technological Foundation, and Beijing WBL Peking University Biotech Co., Ltd. for this study., Author Contributions: Ping Ye collected and interpreted the data and designed and prepared the manuscript. Zong-LiAng Lu was involved in the design and interpreta- 43

coronary event, one coronary death, and one mortality due Journal of the American Geriatric Society Vol 55 No. 7 July 2007 pp. 1015-22 From the Department of Geriatric Cardiology, Chinese PLA General Hospital, Beijing, China; and w Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Medical College, Beijing, China. Address correspondence to Ping Ye, MD, PhD, Department of Geriatric Cardiology, Chinese PLA General Hospital, Beijing 100853, China. E-mail: yeping301@yahoo.com.cn DOI: 10.1111/j.1532-5415.2007.01230.x 45

A 4-year study of Red Yeast Rice extract known as Xuezhikang which lowers cholesterol... Monday, July 27, 2009